Alpha 1 Proteinase inhibitor (Prolastin) Intravenous Infusion for Adults

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Who can administer

May be administered by registered competent doctor or nurse/midwife

Important information

  • Should be prepared by an experienced member of staff (very expensive)
  • Contraindicated in individuals with selective IgA deficiency who are known to have antibodies against IgA, as allergic reactions to the point of anaphylactic shock may occur in such cases
  • Rarely hypersensitivity reactions may occur, even in patients who have tolerated previous infusions of the drug
  • Blood product- record batch number and expiry date in patient's notes

Available preparations

Prolastin 1g powder and solvent for Solution for Infusion

Reconstitution

Water for injection

  • Bring vials to room temperature before reconstitution. Add 40ml per 1g vial (solvent supplied)
  • Use a Mix2Vial device supplied with the product to reconstitute the vial
  • Push the blue end of the Mix2Vial device into the solvent bottle first
  • Place the vial containing the drug on to a flat surface and invert the solvent bottle with the Mix2Vial device still attached
  • While holding the Prolastin Vial securely, push the clear end of the Mix2Vial straight down until the spike penetrates the stopper. The solvent will flow down into the Prolastin vial
    • Note: If the Mix2Vial is connected at an angle, the vacuum may be released from the product vial and the solvent will not transfer- in which case, a needle and syringe will be needed to make the transfer
  • Remove the adaptor with the connected solvent vial in an approximate angle of 45o
  • Gently swirl the concentrate bottle until powder is completely dissolved
  • Do not shake- to avoid foaming
  • Visually inspect for particulate matter and discolouration

Infusion fluids

Not applicable

Methods of intravenous administration

  • The reconstituted solution is added to an empty infusion bag
  • Use a 16Gauge needle (ref BD 300637) to draw up the drug solution
  • Add the total dose to the empty infusion bag

Intermittent intravenous infusion (administer using an electronically controlled infusion device)

  • Use a 500ml empty bag for doses up to 12g and a 1000ml empty bag for doses greater than this
  • Administer at a rate of 4.8ml/kg/hour

Dose in adults

Usual dose

  • Give 60mg/kg every week

Further information

  • Vaccination against Hepatitis A and B is recommended before starting treatment
  • May cause a transient increase in blood volume - use with caution in patients with severe heart failure and in patients at risk of circulatory overload

Order code numbers for empty bags are:

500ml bag (Baxter E3MC-3802),

1000ml bag (Baxter E3MC-3803)

Items required:

BD 16g needles ref 300637- available from surgical stores

Extended intervals

  • No longer recommended (ref 1)
  • A consultant may choose to use a different dosage interval, on an individual patient basis

Storage

  • Store below 250C, do not freeze
  • Prepare infusion immediately before administration
  • Administration must be complete within 3 hours of reconstitution and do not refrigerate after reconstitution

References

SPC January 2026

1: Alpha-1 Foundation in Beaumont (01 8093871) - contacted 8th May 2023

 

Therapeutic classification

Proteinase inhibitor

Search synonym: antitrypsin